Identity
- Trade Name
- medilog DARWIN2 U FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
- Device Name
- The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data pre-recorded on medilog series ambulatory recorders. FDA UDI
- Model / Reference
- 0.282200 FDA UDI
- Description
- The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data pre-recorded on medilog series ambulatory recorders. FDA UDI
Identifiers
- Catalog Number
- 0.282200 FDA UDI
- Primary DI / UDI-DI
- 07613365003758 FDA UDI
- 510(k) Number
- K053369 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyser application software
medilog DARWIN2 U by Schiller Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Schiller Corp.
Sources (1)
- FDA UDI 4bff849e-fe07-4460-b9f2-a634108f4e74 36 fields · synced May 30, 2026